FDA: Page 69
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Brexit happened. EU MDR looms. 3 key questions on medtech's future in Europe
The U.K. can skip the new in vitro diagnostic rules entirely, and in theory, could unilaterally stop applying MDR after the transition period ends. Both scenarios seem unlikely.
By Nick Paul Taylor • Feb. 4, 2020 -
Medtech in limbo as Brexit arrives
Although the industry has lobbied for the departing member state to implement the Medical Device Regulation and stick closely to EU rules, a minister in the U.K. government said legislative alignment “just ain't happening.”
By Nick Paul Taylor • Feb. 3, 2020 -
Explore the Trendlineâž”
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TrendlineMedical device industry continues to turn to AI
While the industry continues to embrace artificial intelligence, there are still questions about how the new technologies need to be regulated and if they are effective.
By MedTech Dive staff -
Amid coronavirus outbreak, FDA and industry seek roadmap for emergency diagnostics
Taking lessons from the Ebola and Zika crises, regulators and manufacturers are meeting Monday to discuss how real-world data could be used to advance more emergency-use diagnostics to full marketing status.
By Maria Rachal • Updated Jan. 31, 2020 -
UK moves to mitigate impact of notified body withdrawals
Several firms pulled their services amid uncertainty about the impact of Brexit, bringing risks into focus.
By Nick Paul Taylor • Jan. 30, 2020 -
Privacy versus access debate rages on, rekindled by Epic lobbying
Promoting interoperability without clear guardrails could lead to healthcare's version of Cambridge Analytica, Epic wrote in a public statement coinciding with ONC's annual health IT conference.
By Rebecca Pifer • Jan. 29, 2020 -
Backing for unique patient identifier picks up steam at ONC conference
A ban on funding UPIs is "misguided policy," Rep. Bill Foster, D-Ill., said Monday at the gathering of IT officials and industry. But other experts warned it's "not a panacea."
By Rebecca Pifer • Jan. 28, 2020 -
CMS widens NGS test coverage for inherited breast, ovarian cancers
The national decision on next generation sequencing tests doesn't go beyond breast and ovarian cancers, but local Medicare contractors are allowed discretion on coverage determinations with other germline cancer diagnoses.
By Maria Rachal • Jan. 28, 2020 -
FDA offers 510(k) advice for arthroscopy pump tubing to prevent cross-patient infections
In a draft guidance on the irrigation tubing used across minimally invasive joint procedures, the regulator said without proper design, testing and risk mitigation, backflow of patient fluid can present risk for disease transmission.
By Maria Rachal • Jan. 27, 2020 -
3 more notified bodies coming soon, EC says as MDR clock ticks down
New designations would move the Commission a step closer to its goal of having 20 notified bodies in place by the end of the first quarter of 2020.
By Nick Paul Taylor • Jan. 23, 2020 -
Surgical gown recall sets Cardinal back $96M
The company estimates a $96 million second quarter charge related to the recall, amid two new field actions affecting procedure kits with the gowns. Cardinal previously saw red flags with the supplier at the root of the problem.
By Nick Paul Taylor • Updated Jan. 31, 2020 -
HHS price transparency efforts may decode only sliver of total spending
A new analysis focused on non-emergency care that a patient can choose deliberately, such as hip or knee replacements, as opposed to emergency services.
By Ron Shinkman • Jan. 21, 2020 -
Supreme Court declines to quickly hear ACA case
It's unlikely the case will be decided before the election, which will thrust the debate over the fate of the landmark law into the spotlight during another presidential campaign.
By Samantha Liss • Jan. 21, 2020 -
UK health authority 'proactively' monitoring breast implant illness reports
In guidance for patients and clinicians on symptoms "sometimes referred to as Breast Implant Illness," the Medicines and Healthcare products Regulatory Agency stopped short of linking the devices to reported illnesses.
By Susan Kelly • Jan. 21, 2020 -
Virtual, augmented reality in medicine pique FDA's interest
The agency is hosting a workshop Wednesday with representatives from Microsoft, Facebook, Philips and other industry players in hopes of identifying roadblocks to developing more uses of extended reality for medical purposes.
By Nick Paul Taylor • Jan. 17, 2020 -
ArcherDX, Geneoscopy, Phagenesis win breakthrough device designations
A cancer relapse test, a colorectal cancer screening test and a device to restore swallowing control are among the latest technologies to benefit from certain regulatory perks.
By Nick Paul Taylor • Jan. 15, 2020 -
Enrollment has ended in Essure postmarket study, FDA says
Bayer discontinued sales of the permanent birth control implant more than a year ago but continues to study its safety profile, as directed by the agency.
By Susan Kelly • Jan. 13, 2020 -
Device warning letters plunged nearly 90% over 5 years. An FDA official predicts a rebound
FDA's device center issued just nine warning letters in the most recent fiscal year, down from 81 in 2015. But with a major reorganization complete, regulators say they can respond to compliance issues more quickly.
By David Lim • Jan. 10, 2020 -
MedTech Europe pushes urgent action to keep devices on sale after MDR
The trade group wants the EU to fix perceived problems with the grace period to allow devices to stay on the market and be reviewed by an MDR-designated notified body.
By Nick Paul Taylor • Jan. 9, 2020 -
FDA sets new date to talk future data strategy
The agency will now convene a public meeting in June, three months after it originally planned, to engage experts on data quality, stewardship, exchange and analytics.
By Nick Paul Taylor • Updated April 28, 2020 -
EU group offers guidance on meeting MDR's cybersecurity standards
The document says it's important to reference the International Medical Device Regulators Forum's cybersecurity guidance, and policies like the General Data Protection Regulation and the EU Cybersecurity Act "might apply in parallel."
By Susan Kelly • Jan. 7, 2020 -
Latest FDA clinical decision support software draft a step forward, industry says
The American Medical Association wrote the guide could "lead to the proliferation of CDS tools for 'non-serious conditions' that are faulty, inaccurate, and without validation, potentially leading to patient harm."
By David Lim • Jan. 7, 2020 -
Industry, doctors, patients diverge on FDA outline for breast implant labels
The Medical Device Manufacturers Association took issue with inclusion of the term "breast implant illness" and called a proposal that manufacturers continually update risk info "impracticable."
By Maria Rachal • Updated Feb. 3, 2020 -
Alex Wong via Getty Images
Providers embrace loosening Stark Law regulations, suggest feds could go further
The Trump administration's proposed relaxation of regulations around the physician self-referral law has nearly unanimous support in both the hospital and physician community.
By Ron Shinkman • Jan. 6, 2020 -
CMS delays clinical lab fee schedule data reporting, cuts capped at 15% for 2021
The decision to maintain the status quo comes despite labs hoping the agency would freeze rate cuts next year.
By David Lim • Jan. 3, 2020 -
Notified bodies MedCert, BSI gain new EU MDR and IVDR designations
The European Commission's latest nods bring total notified bodies designated for the Medical Device Regulation to nine and for the In Vitro Diagnostic Regulation to three.
By Nick Paul Taylor • Dec. 31, 2019
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